Director of Quality & Regulatory Compliance

ROM TECHNOLOGIES INC•Brookfield, CT

17d•Onsite

About The Position

ROMTech is a Class II medical device manufacturer committed to delivering safe, compliant, high-quality products that improve patient recovery outcomes. The Director of Quality & Regulatory Compliance is the senior owner of ROMTech’s Quality Management System (QMS) and FDA regulatory compliance—responsible for ensuring the company is continuously FDA audit-ready, not “audit-ready when we scramble.” This leader serves as the primary FDA regulatory contact and internal compliance authority, owning the systems, governance, and execution required to maintain a robust QMS. This role partners cross-functionally with Manufacturing, Engineering, Supply Chain, IT, and Customer teams to prevent issues, drive corrective action, and uphold product quality and regulatory compliance end-to-end. What Success Looks Like ROMTech is inspection-ready every day: documentation, training, CAPAs, complaints, calibration, audits, and records are complete, current, and defensible. FDA interactions are well-managed, timely, and professional (inspections, submissions, responses). Quality signals (complaints, nonconformances, audit findings) are trended, acted on, and reduced through systemic fixes. The organization knows “what good looks like” through clear procedures, accountability, and routine management review.

Requirements

5–10+ years in Quality / Compliance in medical devices (Class II strongly preferred).
Demonstrated ownership of an FDA-compliant QMS (21 CFR 820 / ISO 13485 environment).
Direct experience leading FDA inspections and managing responses (483s, observations, remediation plans if applicable).
Strong working knowledge of: CAPA, complaint handling, MDR, internal audits Document control and record integrity (incl. DHR/traceability expectations) Calibration systems and measurement control Nonconformance/MRB governance and trending
Proven ability to translate regulatory requirements into practical, adoptable operations.

Responsibilities

Serve as ROMTech’s FDA regulatory contact and lead all FDA inspection hosting, coordination, and response activities.
Maintain FDA establishment registration and related accounts (e.g., GUDID, QS/portal accounts as applicable).
Lead regulatory strategy and manage submissions for FDA clearances/updates as needed (in partnership with Engineering/Clinical/Leadership).
Ensure labeling, intended use positioning, and regulatory commitments are reflected in controlled documentation and execution.
Own the QMS framework: procedures, controls, governance cadence, escalation paths, and continuous improvement.
Lead Management Reviews and ensure performance data and actions are captured, tracked, and closed.
Ensure compliance across core subsystems: document control, training, CAPA, complaints/MDR, audits, calibration, nonconformance, and supplier quality interfaces.
Own the CAPA process end-to-end, including board cadence, prioritization, effectiveness checks, and trend reporting.
Chair (or designate/chair) a CAPA Review Board; ensure corrective actions address systemic root causes, not symptoms.
Ensure a compliant complaint handling program with clear intake, investigation, documentation, closure, and trending.
Oversee MDR decisioning and submissions (with Quality Engineering support), ensuring timeliness and defensibility.
Use complaint trends to drive CAPAs and quality improvements.
Build and maintain the internal audit schedule, train/assign auditors, and ensure audits are executed and closed with appropriate CAPAs.
Track audit performance, systemic gaps, repeat findings, and closure quality.
Own the document control system outcomes (accuracy, integrity, release discipline, archival discipline), including ensuring DHRs/quality records are complete and retrievable.
Partner with Document Control resources (and/or Standards Manager) to ensure the system is scalable and inspection-proof.
Ensure QMS training requirements are defined, assigned, tracked, and audit-ready (completion evidence, role-based matrices, re-training triggers).
Drive training compliance as a quality system, not an HR checkbox.
Ensure an effective calibration program (logs, schedules, external calibration coordination, in-house calibration execution discipline).
Ensure measurement equipment and inspection tools remain within control and traceability expectations.
Provide governance and escalation for the product inspection program (incoming, in-process, final), NCR/NCMR flow, and MRB dispositions—ensuring systemic issues trigger CAPA and supplier actions.
Ensure nonconforming material is controlled, trended, and prevented through upstream fixes.
Ensure quality participation in risk activities (e.g., hazard analysis/FMEA support), verification/validation quality controls, and structured problem-solving (8D/5-Why/DMAIC), in partnership with Quality Engineering and Engineering leadership.